FDA WARNING_LETTER - Double E Dairy LLC - August 04, 2014

On July 17 and August 04, 2014, the FDA inspected Double E Dairy LLC, owned by Mr. Thomas Z. Eaves, Jr., in Lowville, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act related to adulterated animals and drugs.

Specifically, two bob veal calves sold for slaughter were found to have unsafe levels of neomycin residue in their kidney tissue. One calf had 9.83 ppm and another had 29.99 ppm, exceeding the 7.2 ppm tolerance for cattle, and notably, there is no acceptable level for neomycin in pre-ruminating calves. This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found insanitary conditions, including a failure to maintain treatment records, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4).

Furthermore, the firm adulterated the new animal drug (oxytetracycline and neomycin sulfate) by using it in an extralabel manner, specifically by feeding it to a class of animals (bob veal calves) not specified on its approved labeling, and this extralabel use resulted in illegal residues. This violates 21 C.F.R. 530.11(a) and (c),